Select 3D Arterial Cannula with Carmeda Bioactive Surface and Select Cap Arterial Cannula with Carmeda Bioactive Surface

• • Terminated Z-0999-2014 FDA Class II ·initiated 30 Jan 2014

  Medtronic is recalling all models of its Select 3D and Select CAP Arterial Cannula product families due to reports of the cannula body splitting near the suture collar.

• • Terminated Z-1926-2008 FDA Unclassified (pre-2012) ·initiated 9 May 2008

  Medtronic is recalling selected Carmeda-coated cardiopulmonary bypass (CPB) products (e.g., oxygenators, reservoirs, pumps, cannulae and tubing packs) that were manufactured with contaminated heparin. Medtronic's heparin supplier recently reported that it had provided some batches to Medtronic that were contaminated with oversulfated chondroitin sulfate (OSCS).

510(k) Number

K033416 ↗

FDA Product Code

DWF

Device Class

Class II

Regulation

21 CFR Part 870.4210

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

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  Class II

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• Eopa 3D Arterial Cannula, Models 78220, 78222, 78320, 783222

  Class II

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• Bio-Console 560

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• Magellan Ratio Dispenser Kit/Magellan Spray Tip/Magellan Cannula Tip

  Class II

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• Bio-Console, Model 560

  Class II

  FDA 510(k) K051303 Active Cleared 10 Jun 2005

See all devices from Medtronic Perfusion Systems →